Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization

Not Applicable

Active, not recruiting

• Conditions: Coronary Intervention; Transradial Approach

• Registration Number: NCT05966376
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.

Detailed Description

INTRODUCTION AND BACKGROUND

Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that this approach method mainly reduces the occlusion rate of the proximal radial artery, among other advantages; however, we still do not have scientific evidence on the various hemostasis methods for this approach. Practice varies between centers and countries and hemostasis methods vary from an elastic compression bandage to the use of devices manufactured specifically for this approach such as the PreludeSYNC DISTAL or modification of devices manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we intend to analyze the efficacy and safety of two hemostasis methods in patients who require an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no clinical trial that compares these methods face to-face in relation to their efficacy and safety. Retrospective studies indicate that both methods are effective in reducing radial artery occlusion and are safe in reducing the bleeding/hematoma rate.

THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR band) in patients undergoing percutaneous coronary intervention.

STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and comparative.

SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will undergo distal radial percutaneous coronary intervention/angiography.

METHODOLOGY After signing the informed consent, patients will be randomized by balanced block methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the Modified Radial Band device.

PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

• Coronary artery disease including chronic coronary syndrome or acute coronary syndrome.
• Cardiovascular disease that requires coronary angiography in its approach.

Exclusion Criteria

• Cardiogenic shock.
• Lesions in venous or arterial hemoducts.
• Impossibility to provide informed consent.
• Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned.
• Severe chronic renal failure (GFR less than 30 ml/min/m2)
• Patients diagnosed with cancer.
• Patient with rheumatological and hematological pro-thrombotic disorders.
• Non-hydrophilic radial introducer.
• Failed cannulation of the radial artery with an introducer.
• Successful trans-radial access that is crossed over to the femoral approach.
• Patients with an interventional procedure using a radial approach in the previous 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.	24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.	At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.

Secondary Outcome Measures

Name	Time	Method
Bleeding at the access site.	24 hours after the procedure.	Evaluated by clinical signs.
Neurological sequelae.	24 hours after the procedure.	Evaluated by clinical signs.
Incidence of hematoma at the approach site.	24 hours after the procedure.	Evaluated by clinical signs. Classified according to EASY scale.
Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.	24 hours after the procedure.	Evaluated by clinical signs and doppler.
Incidence of radial artery pseudoaneurysms.	24 hours after the procedure.	Evaluated by clinical signs and ultrasound doppler.
Radial arterial patency at 30 days in patients with obstruction at 24 hours.	30 days after the procedure	Evaluated by clinical signs and ultrasound doppler.

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia Ignacio Chávez; 🇲🇽 Mexico City, Mexico